U.S. patent number 3,683,927 [Application Number 05/064,749] was granted by the patent office on 1972-08-15 for method and cartridge for ligating organic tubular structures.
This patent grant is currently assigned to United States Surgical Corporation. Invention is credited to Douglas G. Noiles.
United States Patent |
3,683,927 |
Noiles |
August 15, 1972 |
METHOD AND CARTRIDGE FOR LIGATING ORGANIC TUBULAR STRUCTURES
Abstract
A method and a staple cartridge for ligating a hollow organic
tubular structure by means of surgical staples. The organic tubular
structure is loosely confined within an area which is variable in
accordance with the position of the ligating surgical staples. The
staples, being U-shaped are moved toward the organic tubular
structure, thereby decreasing the confining area, until the arms of
the staples begin to bend around the structure. The staple arms are
bent until they encircle the tubular structure and contact one
another; then the staples are further deformed, by acting on the
surfaces remote from the contacting arms, until the tubular
structure is completely sealed. During the staple-bending
operation, the periphery of the tubular structure is positively
controlled by the ligating cartridge, thereby ensuring the
integrity of the structure.
Inventors: |
Noiles; Douglas G. (New Canaan,
CT) |
Assignee: |
United States Surgical
Corporation (Baltimore, MD)
|
Family
ID: |
22058038 |
Appl.
No.: |
05/064,749 |
Filed: |
August 18, 1970 |
Current U.S.
Class: |
606/143; 227/19;
29/243.57 |
Current CPC
Class: |
A61B
17/128 (20130101); Y10T 29/53787 (20150115); A61B
17/32 (20130101) |
Current International
Class: |
A61B
17/12 (20060101); A61B 17/128 (20060101); A61B
17/32 (20060101); A61b 017/10 (); A61b
017/12 () |
Field of
Search: |
;128/305,325,326,334R,346 ;29/243.57,33.5 ;227/19 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A cartridge adapted for removable insertion on a medical
instrument and having the capability of confining an organic
tubular structure in a closed area, causing the encirclement of the
structure with a surgical staple, and causing the ligation of the
structure with said surgical staple, the cartridge comprising: a
first guide track assembly; a second guide track assembly movable
relative to said first guide track assembly; said first and said
second guide track assemblies being shaped and associated in such a
manner as to define first and second positions; staple guide means
extending along the length of said first and said second guide
track assemblies for guiding the movement of and the bending of a
surgical staple; curved anvil means on said first guide track
assembly; said first and second guide track assemblies and said
curved anvil means defining, when said first and said second guide
track assemblies are in their first position, an open housing; and
said first and said second guide track assemblies and said curved
anvil means defining, when said first and said second guide track
assemblies are in their second position, a continuous U-shaped
guide path; and pusher means adapted for movement along and in the
plane of said guide path when said first and said second guide
track assemblies are in their second position; wherein said pusher
means has a curved face adjacent the curved face of said anvil
means; wherein the curvature of said anvil means is less severe
than the curvature of said pusher means; and wherein said first and
said second guide track assemblies, said anvil means and said
pusher means are shaped and associated so that when a U-shaped
surgical staple is positioned in said guide track means with the
arms thereof extending toward said anvil means, and when said
staple is urged toward said anvil means by said pusher means, the
arms of said staple are guided by said guide path until they
contact one another and are bent into the shape of said rounded
anvil means, the bridge of said staple remote from the contacting
arms thereof is collapsed, and the staple is deformed between said
anvil means and said pusher means into a C-shape sealing said
organic tubular structure.
2. The cartridge defined in claim 1, and further comprising:
respective second sets of guide track assemblies, anvil means and
pusher means, spacially aligned with respect to the first sets
thereof; said first and said second sets for sealing said organic
tubular structure at first and second locations; and knife means
for dividing said sealed organic tubular structure intermediate
said first and second positions.
3. The cartridge recited in claim 1, wherein said first guide track
assembly is adapted to be securely mounted on a medical instrument;
wherein said second guide track assembly is slidably mounted with
respect to said first guide track assembly; and wherein said pusher
means is slidably mounted for movement relative both to said first
and said second guide track assemblies.
4. The invention set forth in claim 3, wherein said pusher means
slides between said first and said second guide track
assemblies.
5. The cartridge recited in claim 1, and further comprising: means
on said first and said second guide track assemblies for ensuring
smooth mating therebetween when said guide tract assemblies are
moved from their first position to their second position.
6. The cartridge defined in claim 1, wherein said second guide
track assembly is integral with a main body portion; wherein said
first guide track assembly is slidably mounted in said main
portion; and wherein said pusher means is slidably mounted within
said main body portion.
7. The cartridge recited in claim 6, and further comprising:
respective second sets of guide track assemblies, anvil means and
pusher means, spacially aligned with respect to the first sets
thereof; said first and said second sets for sealing said organic
tubular structure at first and second locations; and knife means
for dividing said sealed organic tubular structure intermediate
said first and second positions.
8. The cartridge recited in claim 1, wherein the face of said anvil
means conforms to the circumference of a first circle; wherein the
face of said pusher means conforms to the circumference of a second
circle; and wherein the radius of said first circle is larger than
the radius of said second circle by an amount at least equal to two
staple thicknesses.
9. The cartridge defined in claim 1, and further comprising: first
and second guide discs associated with said curved pusher means for
ensuring positive contact and alignment between said pusher means
and said staple.
10. A method of surgically ligating an elongated organic structure
of a patient by the use of a surgical staple, the method comprising
the steps of; incising the patient to expose the elongated organic
structure to be ligated; positioning a ligating instrument in the
region of said organic structure; freeing and inserting said
organic structure in a closed housing of the ligating instrument
defined by the walls of a U-shaped guide track and an opposing
U-shaped surgical staple; closing the area wherein said organic
structure is housed by moving said U-shaped surgical staple in said
guide path; initially bending said U-shaped surgical staple, along
said U-shaped guide path, until the extremities of the arms thereof
contact one another; collapsing the bridge of said U-shaped staple
until the collapsed staple takes a C-shape and ligates said organic
structure; removing the ligating instrument from the region of said
organic structure; and closing the incision made in the
patient.
11. The surgical method recited in claim 10, wherein the U-shaped
guide track terminates in a curved anvil surface; and wherein the
U-shaped staple is moved and bent by a pusher having a curved
face.
12. The surgical method recited in claim 11, wherein the curvature
of said anvil face is less severe than is the curvature of said
pusher face.
13. The surgical method defined in claim 12, wherein the curvature
of said anvil face conforms to the circumference of a first circle;
wherein the curvature of said pusher face conforms to the
circumference of a second circle; and wherein the radius of said
first circle is greater than the radius of said second circle by at
least two staple widths.
14. The surgical method according to claim 10, and further
comprising the steps of: simultaneously ligating the elongated
organic structure with a second staple spaced from the first
staple: and dividing the elongated organic structure at a location
intermediate said first staple and said second staple.
Description
BACKGROUND OF THE INVENTION
In recent years, the use of staples in surgery has grown
considerably in popularity. For example, there are several
automatic stapling instruments and cartridges which have been
designed for ligating and dividing hollow tubular organic
structures. Three known cartridges, which will be described below,
operate by first constricting the structure to be ligated between
the jaws of the cartridge and then encircling the structure with a
pair of surgical staples until the structure is sealed. Each of
these known cartridges suffers from one serious drawback.
In copending U.S. Pat. application Ser. No. 672,362, filed on Oct.
2, 1967, now U.S. Pat. No. 3,545,444, and assigned to the present
assignee, a ligating surgical cartridge is disclosed which operates
by first constricting the organic tubular structure to be ligated,
between its jaws, and by then bending a pair of relatively linear
staples around the structure until the structure is sealed off.
During the bending of the staples, there are portions of the
tubular structure which are out of the control of the cartridge.
That is, there are portions of the tubular structure which are free
from the positive constraining effects of the cartridge jaws, and
which, therefore, are able to flex as a result of forces centered
about other portions thereof. Due to this lack of positive control,
the danger exists that the staples, when encircling the tubular
structure, may pierce or scratch the structure. And when dealing
with organic structures, such as blood vessels, punctures and
surface damage may lead to severe problems.
In copending U.S. Pat. Application Ser. No. 766,680, filed Oct. 11,
1968, now Pat. No. 3,584,628, and copending U.S. Pat. application
Ser. No. 32,247, filed Apr. 27, 1970, each assigned to the present
assignee, two improved ligating cartridges are disclosed. In each
of the improved cartridges, the shape of the unbent staples is made
non-linear, thereby resulting in a more effective closure of the
organic tubular structure. However, notwithstanding the more
effective staple shape, there are still areas of the tubular
structure which remain out of the control of the surgical
cartridge. And, as described above, this lack of control carries
with it the danger that the organic tubular structure may be
pierced or scratched by the ligating staples.
It is toward the elimination of these prior art drawbacks that the
present invention is directed.
SUMMARY OF THE INVENTION
The present invention relates to a method and a cartridge for
applying a pair of ligating surgical staples to an organic tubular
structure in such a manner that the integrity of the structure is
ensured. More particularly, the inventive method and cartridge
eliminate the drawbacks of the prior art by providing positive
control of the entire surface of the tubular structure during the
staple-bending portion of the ligating operation. In this manner,
the ligating staples encircle the organic tubular structure without
the danger of piercing or scratching the surface thereof.
The present invention contemplates that the organic tubular
structure to be ligated, be loosely positioned within the jaws of a
ligating cartridge. The area within which the tubular structure is
maintained, being defined by a pair of linear side walls of the
cartridge, a curved anvil integral with the cartridge, and a pair
of movable U-shaped staples, is then gradually reduced by moving
the U-shaped staples toward the anvil. With continued movement of
the staples, their arms are bent around the anvil, encircle the
tubular structure, and close upon one another. Then, the region of
each staple remote from the point of contact between the staple
arms is deformed and urged toward the contacting staple arms, this
deformation continuing until the organic tubular structure is
completely sealed. During the staple-bending portion of the
ligation, the entire periphery of the organic tubular structure is
positively controlled.
In the manner described above, the danger of piercing or marring
the surface of the organic tubular structure is eliminated. By
positively controlling the entire surface area of the tubular
structure, during the staple-bending stage of the procedure, it is
possible to safely bend a surgical staple entirely around the
structure, even with the staple contacting the structure during the
bending operation. This principle of operation of the present
invention can easily be demonstrated by the reader with the aid of
his finger, a pin and a smooth surface. If the reader presses his
finger against a smooth surface, he is able to slide a pin between
his finger and the smooth surface, without injury, if he maintains
the point of the pin in contact with the smooth surface. Similarly,
with the arms of the U-shaped staples in continuous contact with
the U-shaped anvils during the bending of the staple arms around
the organic tubular structure, the staples are bent without injury
to the tubular structure.
Accordingly, it is the main object of the present invention to
provide a method and an apparatus for ligating an organic tubular
structure with a surgical staple, in a manner which ensures the
integrity of the organic structure.
It is another object of the present invention to provide a method
and an apparatus for safely ligating organic tubular structures by
means of surgical staples and by doing so in an extremely simple
manner.
Still a further object of the present invention is to provide a
method and an apparatus for safely and efficiently ligating an
organic tubular structure by means of surgical staples, by
controlling the surface area of the tubular structure at all times
during the ligation.
These and other objects of the present invention, as well as many
of the attendant advantages thereof, will become more readily
apparent when reference is made to the following description taken
in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of a surgical cartridge, showing a portion of
an associated firing instrument, designed in accordance with the
teachings of the present invention;
FIG. 2 is a cross-section of the cartridge taken along line 2--2 of
FIG. 1;
FIG. 3 is a side view of the main body of the surgical cartridge
illustrated in FIG. 1;
FIG. 4 is a top view of the main body illustrated in FIG. 3;
FIG. 5 is a top view of the inventive cartridge illustrated in FIG.
1;
FIG. 6 is a cross-section of the inventive cartridge taken along
line 6--6 of FIG. 5;
FIG. 7 is a cross-section of the cartridge taken along line 7--7 of
FIG. 6;
FIG. 8 is a cross-section similar to FIG. 7 but showing a portion
of the inventive cartridge during the early stages of ligation;
FIGS. 9 through 12 are enlarged cross-sections through the
inventive cartridge showing the staple formation during various
stages of the ligation; and
FIG. 13 is a front view of a staple showing the manner in which the
mating of the staple arms takes place.
DETAILED DESCRIPTION OF THE DRAWINGS
With reference first to FIGS. 1 and 2, the basic cartridge and its
attachment to the firing instrument will be described. The
cartridge is shown generally at 10 and comprises a three-piece main
body portion 12, a pair of three-piece rail assemblies 14 and a
pair of pushers 16. The firing instrument is shown generally at
18.
The firing instrument 18 may be of the type described in either
U.S. Pat. application Ser. No. 766,680 or U.S. Pat. application
Ser. No. 32,247, each mentioned above; and for purposes of
description, only a portion of the firing instrument 18 will be
described.
The instrument 18, at its forward end, is provided with a groove 20
and a thumb-operated cover plate 22; and as seen in FIGS. 1 and 5,
the cartridge 10, at the rear end of the rail assemblies 14, is
provided with a coupling bar 24. Bar 24 is adapted to mate with the
groove 20 and is held in position by the cover plate 22. The three
elements of each rail assembly 14 are maintained in proper
alignment by a plastic form 26, and the coupling bar 24 ensures
unity between the rail assemblies and the form 26. Cover plate 22
contacts the lower surface of the form 26.
The output of the firing instrument 18 takes the form of a pair of
shafts 28 and 30, each movable with respect to the front nose 32 of
the firing instrument 18. Shaft 28 lies within hollow shaft 30 and
is movable with respect thereto. On the forward end of the shaft 28
are positioned a pair of shoulders 34, and on the forward end of
the shaft 30 are positioned a pair of shoulders 36. While the
complete operation of the firing instrument 18 is not herein
explained, suffice it to say that upon activation of the instrument
18, the shafts 28 and 30, with their respective shoulders 34 and
36, move in unison, away from the front nose 32 of the instrument
18. A biasing spring operates between the shafts 28 and 30 and
consequently between the shoulders 34 and 36. Therefore, when a
differential force is exerted between the shafts 28 and 30, of a
magnitude greater than that of the biasing spring, relative motion
takes place and the shoulders 34 move away from the shoulders 36.
The operation of the firing instrument 18, as it affects the
operation of the cartridge 10, will be explained below.
As clearly seen in FIGS. 1 and 3, the rear region of the body 12 is
provided with a depression 38 adapted to mate with the forwardmost
of the two shoulders 36. The other shoulder 36 contacts the rear of
the main body 12. And, as seen in FIG. 1, the rear region of each
pusher 16 is provided with a notch 40, adapted to mate with the
forwardmost of the two shoulders 34. The other shoulder 34 contacts
the rear of the pusher 16. Therefore, the shoulders 34 and 36
serve, respectively, as saddles within which the pushers 16 and the
main body 12 are seated and controlled.
Now, with reference to FIGS. 2 through 7, the elements of the
cartridge 10 will be described.
The three-piece main body 12, as shown best in FIGS. 2 and 7, takes
the form of a central body member 42 sandwiched between a pair of
cover plates 44. The central body member 42 and the cover plates 44
are held together by means of four rivets or bolts 46. As seen best
in FIGS. 2 and 3, the central body member 42, when covered by
plates 44, is provided with a first elongated groove 48 and a
second elongated groove 50, groove 48 being the deeper of the two.
The groove 48 may be termed a rail guiding groove and the groove 50
may be termed a staple and pusher guiding groove.
The forward end of the central body member 42 is thin, is
elongated, and is tapered at its extremity, as indicated by the
numeral 52. Slightly rearward of the taper 52, for reasons which
will become apparent from the following, a section is removed from
each side of the forward end of the main body member 42. Each side
of the main body member 42, where a section is removed, has defined
therein an angled sloping indented wall 54.
The rear portion of the central body member 42, which is adapted to
mate with the firing instrument 18, is open as shown at 55. In this
manner, the shafts 28 and 30, and their associated shoulders 34 and
36, are easily associated with the main body.
With reference now to FIGS. 5 through 7, the construction of the
rail assemblies 14 will be described. As can be seen in FIGS. 5 and
7, the cartridge 10 includes a pair of rail assemblies 14, each of
these assemblies being of three-piece construction. Each rail
assembly 14 comprises a central guide rail 56, an outer restraining
plate 58 and an inner restraining plate 60. Inner restraining plate
60 is wider than outer restraining plate 58, so as to ensure that
the guide rails 14 remain in the rail guiding grooves 48, defined
between the central body member 42 and the cover plates 44. The
integrity of each three-piece rail assembly 14 is ensured by a pin
61 passing through the outer restraining plate 60, at the forward
end thereof, and the plastic form 26, with its bar 24, at the rear
thereof.
As best seen in FIG. 6, the respective forward ends of the outer
restraining plate 58 and the inner restraining plate 60 are cut at
an angle, as shown at 66, so as to mate with the sloping wall 52 on
the central body member 42. Similarly, the forward end of the guide
rail 56 is cut at an angle, as shown at 64, so as to mate with the
taper 54 on the central body member 42. Therefore, and as
illustrated in FIG. 8, the mating of the faces 52 and 66 and the
mating of the faces 54 and 64 is smooth and positive, so that the
rail assembly 14 mates with the main body 12 defining a continuous
anvil region 86.
Now, with reference to FIGS. 2 and through 10, the construction of
the pushers 16 will be described. Each pusher 16 is elongated, is
of a height substantially equal to that of the staples and that of
the pusher guiding groove 50, and is of a width slightly in excess
of the thickness of a staple, shown at 68. The forward end of each
pusher 16 is diminished in height from the remaining portions of
the pusher and is rounded as shown at 70 in FIG. 10. For reasons
which will become clear from the following, the rounded portion of
each pusher takes a shape so as to comfortably unite with the
rounded anvil regions 86. The radius of the curved pusher faces is,
however, less than the radius of the curved anvils so as to allow
for the intermediate positioning of the organic tubular structure
and two thicknesses of the staple. On each flat side of the rounded
projection 70 a circular restraining disc 72 is secured. As best
seen in FIGS. 7, 9 and 10, the discs 72 ensure that the staples 68
are held in proper alignment with the rounded projections 70 of the
pushers 16, and as can be seen in FIG. 2, the shape of the grooves
50 allows for the presence of these discs. The width of the pushers
16 is equal to the width of the respective central guide rails 56.
Therefore, the bottom portions of the pushers 16 are guided by the
guide rails 56. The pushers are restrained against unwanted
transverse motion by the shape of the groove 50 and the restraining
plates 58 and 60.
Now, the operation of the inventive cartridge will be explained. As
can be seen in FIG. 1, and like the cartridges disclosed in the
above-mentioned copending patent applications, the inventive
cartridge is made removable from the firing instrument, is made
disposable, and may be presterilized and packaged for shipment to
the surgical arena.
For a discussion of the cartridge operation, the attention of the
reader is directed to FIGS. 1 and 8 through 12. With the cartridge
10 mounted on the firing instrument 18, an organic tubular
structure 76, such as a blood vessel, is inserted between the open
respective ends of the rail assemblies 14 and the main body 12
(FIG. 1). Arrow 74 indicates the manner in which the structure 76
is inserted. When the structure is in position, as shown in phantom
in FIG. 1, the surgeon activates the firing instrument 18.
The initial action of the surgeon-operated firing instrument 18 is
to simultaneously move the shafts 28 and 30, and thus the shoulders
34 and 36, away from the front nose 32 of the firing instrument 18.
As a result of the integrity between the shoulders 34 and the
pushers 16, and the integrity between the shoulders 36 and the main
body 12, the main body 12 of the cartridge 10, in unison with the
pushers 16, move relative to the rail assemblies 14. That is, the
main body 12 and the pushers 16 move in the direction of arrows 78
(FIG. 6), the rail assembly 14 remaining stationary, being rigidly
secured to the firing instrument 18. This relative motion continues
until the mating of the main body 12 with the rail assemblies 14,
as illustrated in FIG. 8.
Once the mating faces of the main body 12 and the rail assemblies
14 come into contact with one another, the main body can no longer
move in the direction of the arrow 78. Accordingly, continued force
exerted on the firing instrument 18 by the surgeon results in no
relative motion of elements until the differential force between
the shafts 28 and 30 is reached. However, once this differential
force is reached, the shaft 28 moves forward within and with
respect to the shaft 30. Accordingly, shoulders 34 move away from
shoulders 36. Since the shoulders 34 are in direct association with
the pushers 16, the pushers 16 move in the direction of arrow 80
shown in FIG. 8, the main body 12 and the rail assemblies remaining
stationary.
Once the pushers 16 begin to move relative to the main body 12, a
pair of staples 68 are carried by the pushers along their
respective guide tracks 82 and 84, shown in FIGS. 7 and 8. At this
time, the organic tubular structure 76 is loosely housed within the
closed area defined by the guide tracks 84, the anvil regions 86
and the inner walls of the central body member 42. When the staples
are moved in the direction of arrow 80 and reach the inner walls of
the member 42, the confining area is then defined by the guide
tracks 84, the anvil regions 86 and the inner walls of the U-shaped
staples 68. The limiting confining area, before staple bending, is
illustrated in FIG. 9.
From the initial movement of the staples 68 until the arms of the
staples contact the anvil regions 86, pusher movement merely moves
the staples in the direction of arrow 80 and diminishes the area in
which the tubular structure is housed. Preferably, by the time when
the arms of the staples contact the anvil regions, the organic
structure 76 is positively controlled in all regions of its
periphery, by the anvil regions 86 and the inner walls of the
staples 68. See FIG. 9. While it is preferable that the tubular
structure be of a size substantially as shown in FIG. 9, this
sizing is not absolutely essential.
When the pusher 16 moves from the position shown in FIG. 9, that
wherein the staple arms meet the anvil regions, into the position
shown in FIG. 10, the arms of the U-shaped staples 68 ride along
the curved walls of the anvils 86 and are bent by the anvils. At
first, the staples bend as shown in FIG. 10, but further pusher
movement forces the mating arms of the staples 68 to take the shape
of the anvils 86. Then, the respective regions of the staples
remote from the mating walls begin to collapse, the staples taking
the form shown in FIG. 11. Here it can be seen how the arms of the
U-shaped staples are forced tightly against the curved anvil 86 and
how the bridges of the staples begin to collapse. With continued
movement of the pushers 16, the associated staples collapse until
the tubular structure 76 is completely closed within the pair of
collapsed staples 68, as shown in FIG. 12.
To ensure that the arms of the staples 68 properly mate with one
another and to ensure that the staple collapse is proper, the
extremities of the staple arms are preferably shaped as shown in
FIG. 13. In this Figure, it is seen that one arm of the staple 68
is V-shaped while the other arm is pointed. The dimensions of the
points are matched to the dimensions of the V thereby ensuring
positive contact therebetween. And, as seen in FIGS. 9 through 12,
the forward ends of the staple arms may be wedge-shaped so as to
ensure that the organic tubular structure is pushed out of the way
of the closing staples. The staples are made resilient and are made
to have a relaxed arm-to-arm dimension in excess of the distance
between the tracks in which they ride. In this manner, the staples
are biased against the guide tracks at all times during their
advancement and during the bending operation.
As described above, the inventive cartridge comprises a pair of
rail assemblies, a pair of pushers, and is designed to eject a pair
of staples for each activation of the firing instrument. In this
manner, when a unitary tubular structure is positioned within the
jaws of the inventive cartridge and the associated instrument is
fired, a pair of spaced apart staples close the tubular structure
in two spaced locations. Therefore, it is then possible to sever
the tubular structure at any point intermediate the two staple
positions without significant loss of blood. For this purpose, the
instrument is preferably provided with a knife 88 which may be
associated with an externally positioned thumb-operated control bar
90. Therefore, once the pair of staples is secured in the structure
76, thus closing same in two positions, the control bar 90 may be
moved forward until the knife 88 severs the associated tubular
structure intermediate the pair of staples. Then, for example, the
surgeon is able to clear the interfering tubular structure from the
surgical field.
Above, a specific embodiment of the present invention has been
described. It should be appreciated, however, that this embodiment
is described for purposes of illustration only and that numerous
alterations and modifications may be practiced by those skilled in
the art without departing from the spirit and scope of the
invention. Accordingly, it is the intent that the invention not be
limited by the above but be limited only as defined in the appended
claims.
* * * * *